WASHINGTON (AP) — Pfizer’s COVID-19 pill appears to provide little or no benefit to young adults, while reducing the risk of hospitalization and death in high-risk older adults, according to a large study released Wednesday.
The results of an Israeli study of 109,000 patients are likely to renew questions about the US government’s use of Paxlovid, which has become the gold standard treatment for COVID-19 due to its convenience at home. The Biden Administration spent more than $10 billion to buy the drug and make it available in thousands of pharmacies through its test and treat initiative.
Researchers found that Paxlovid reduced hospitalizations in people aged 65 and over by about 75% when given soon after infection. This matches previous results used to license the drug in the United States and other countries.
But people between the ages of 40 and 65 saw no measurable benefit, according to analysis of medical records.
The study has limitations due to its design, which compiled data from a large Israeli health system rather than enrolling patients in a randomized study with a control group – the gold standard for medical research.
The results reflect the changing nature of the pandemic, in which the vast majority of people already have some protection against the virus through vaccination or previous infection. For young adults, in particular, this greatly reduces their risk of serious complications from COVID-19. Centers for Disease Control and Prevention recently estimated that 95% of Americans 16 and older have acquired some level of immunity to the virus.
“Paxlovid will remain important for those most at risk of severe COVID-19, such as the elderly and those with weakened immune systems,” said Dr. David Boulware, a researcher and physician at the University of Minnesota, who did not participate in the study. “But for the vast majority of Americans who are now eligible, it really doesn’t have much of a benefit.”
A Pfizer spokesperson declined to comment on the results, which were published in the New England Journal of Medicine.
The United States Food and Drug Administration authorized Paxlovid at the end of last year for adults and children 12 and older who are considered high risk due to conditions such as obesity, diabetes and heart disease. More than 42% of American adults are considered obese, which represents 138 million Americans, according to the CDC.
At the time of the FDA’s decision, there were no options for treating COVID-19 at home, and Paxlovid was considered essential to reducing hospitalizations and deaths during the second winter surge of the pandemic. The drug’s results were also much stronger than a competing pill from Merck.
The FDA made its decision based on a study by Pfizer in high-risk patients who had not been vaccinated or treated for prior COVID-19 infection.
“These people do exist, but they are relatively rare because most people have now been vaccinated or infected,” Boulware said.
Pfizer reported earlier this summer that a separate study of Paxlovid in healthy adults — vaccinated and unvaccinated — showed no significant benefit. These results have not yet been published in a medical journal.
More than 3.9 million prescriptions for Paxlovid have been filled since the drug was authorized, according to federal records. A course of treatment is three tablets twice a day for five days.
A White House spokesperson on Wednesday pointed to several recent articles suggesting Paxlovid helps reduce hospitalizations in people 50 and older. The studies have not been published in peer-reviewed journals.
“The risk of serious consequences from COVID is along a gradient, and the growing body of evidence shows that people aged 50 to 64 can also benefit from Paxlovid,” Kevin Munoz said in an emailed statement. mail.
Administration officials have been working for months to increase the use of Paxlovid, opening thousands of sites where patients who test positive can fill a prescription. Last month, US officials even greater access by allowing pharmacists to prescribe the drug.
The White House recently signaled that it may soon stop buying COVID-19 vaccines, drugs and tests, shifting responsibility to the private insurance market. In this scenario, insurers could set new criteria for determining when they would pay for patients to receive Paxlovid.
Follow Matthew Perrone on Twitter: @AP_FDAwriter
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.